Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital
• Collaborators: Eisai China Inc.; Xuanwu Hospital, Beijing
• Treatments: Donepezil

Criteria

Inclusion Criteria:

1. 50 ≤ years of age < 85years.

2. Patients newly diagnosed as probable AD based on NINCDS- ADRDA (1984); Mild to moderate AD with MMSE10-24, modified Hachinski ischaemic scale (MHIS)≤4, ADL≥23,HAMD<7.

3. MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2).

4. 5mg daily of Donepezil for at least four weeks before enrollment.

5. Patient with exclusive caregiver.

6. Move freely with or without walking aid.

7. With good eyesight and hearing, can cooperate with the examination and treatment.

8. Patient and caregiver who signed the written informed consent form for the terms of personal and medical information.

Exclusion Criteria:

1. With Vascular dementia or other types of dementia. Accompanied by other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc).

2. With type I diabetes, obstructive lung disease or asthma, vitamin B12 or folic acid deficiency, thyroid dysfunction, severe liver or kidney dysfunction, severe cardiac insufficiency (congestive heart-failure, myocardial infarction, Sick Sinus Syndrome, II-III degree atrioventricular block or heart rate<50bpm).

3. Epilepsy or head trauma resulted in unconsciousness once occured in the past two years.

4. Blood diseases (such as anemia, granulocytes, leukemia, etc) or tumor 5. With Hematologic Disease or neoplasms within past 2 years.

5. Has a history of alcohol dependence and drug abuse.

6. With known hypersensitivity to medicines or foods.

7. Taking anticholinergic agents or antihistaminic agents.

8. Patients who had been hospitalized continuously for more than 3 months before screening.